Safety Report: Citi Trade Int’l Limited Notoginseng Formula Special Gout Granule - recalled due to undeclared drugs, USA

United States

8th Avenue Pharmacy is voluntarily recalling all lots within the expiry of Notoginseng Formula Special Gout Granule, distributed by 8th Avenue Pharmacy, to the consumer level. The products have been found to contain undeclared diclofenac and dexamethasone from FDA laboratory analysis. Notoginseng Formula Special Gout Granule was distributed Nationwide via retail and e-commerce platforms including Amazon, Shopify, and eBay, as well as at the 8th Avenue Pharmacy location in Brooklyn, New York. To date, 8th Avenue Pharmacy has not received any reports of adverse events related to this recall.

Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAID). NSAIDs may cause an increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries, and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Only licensed healthcare professionals can evaluate patients for the risk or existence of adrenal suppression. In addition, the undeclared dexamethasone in Notoginseng Formula Special Gout Granule may cause serious side effects when combined with other medications.

The product recall includes all lots within the expiry of the Notoginseng Gout Formula granule distributed by 8th Avenue Pharmacy. The product is a tea that is marketed as a gout treatment and is packaged in an orange and white box containing 10 tea packs. The product can be identified by UPC 6952115888087.

Consumers taking Notoginseng Formula Special Gout Granule should immediately consult their health care professional to safely discontinue the use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Abrupt discontinuation can cause withdrawal symptoms.

Consumers/distributors/retailers that have Notoginseng Formula Special Gout Granule can return to the place of purchase or discard it. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: 8th Avenue Pharmacy
Brand name: Citi Trade Int’l Limited
Product recalled: Notoginseng Formula Special Gout Granule
Reason for the recall: Undeclared drugs, Diclofenac and Dexamethasone
FDA Recall date: December 15, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/8th-avenue-pharmacy-issues-voluntary-nationwide-recall-notoginseng-formula-special-gout-granule-due